Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07218926 | A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy | PHASE3 | RECRUITING | 450 | — | — | Dec 3, 2025 | Nov 29, 2030 | May 27, 2026 | 121 | United States, Australia +16 |
| NCT05489237 | First-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors | PHASE1 | RECRUITING | 278 | — | — | Aug 3, 2022 | Jun 28, 2028 | May 4, 2026 | 31 | United States, Belgium +9 |
PFS is defined as time from the date of randomization to the date of disease progression or death due to any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| IDRX-42 (GSK6042981) | EXPERIMENTAL | - |
| Sunitinib | ACTIVE_COMPARATOR | - |
| Dose Escalation (Phase I) | EXPERIMENTAL | Participants should have advanced (metastatic and/or surgically unresectable) GIST, following failure of at least prior imatinib therapy due to progression of GIST. |
| (Phase 1b) Cohort 1 - Participants with GIST progression after first-line imatinib therapy | EXPERIMENTAL | Participants with advanced GIST who have had GIST progression after first-line imatinib only (second line therapy setting) and refused or are ineligible for other standard of care (SOC) therapies. |
| (Phase 1b): Cohort 2 - Participants with GIST progression after 2 or more lines of TKI therapy | EXPERIMENTAL | Participants with metastatic and/or surgically unresectable GIST following progression EITHER after sequential imatinib then sunitinib (third-line therapy setting) OR after imatinib, sunitinib, and then an additional TKI agent (i.e., regorafenib or ripretinib) (fourth-line therapy setting) OR after imatinib, sunitinib, regorafenib, and ripretinib (5th line or greater therapy). |
| (Phase 1b): Cohort 3 - Participants with GIST who are treatment naïve | EXPERIMENTAL | Participants with metastatic and/or surgically unresectable GIST who are treatment naïve (first line therapy) and refused or are ineligible for other standard of care (SOC) therapies. |
| (Phase 1b): Cohort 4 | EXPERIMENTAL | Participants with GIST progression who meet the same criteria as Cohort 2 (third line or greater TKI therapy) and have had prior treatment with investigational agents NB003 or THE-630 or a line of therapy of bezuclastinib plus sunitinib combination. |
| Name | Type | Description |
|---|---|---|
| IDRX-42 | DRUG | IDRX-42 will be administered. |
| Sunitinib | DRUG | Sunitinib will be administered. |
Inclusion Criteria: * Participants with histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable. * Documented disease progression on or intolerance to imatinib administered for first-line treatment of unresectable/metastatic disease. * Tumor tissue must be a...